Make the Creating Hope Act Permanent

The Creating Hope Act pediatric priority review voucher program has been wildly successful. It is critical that Congress reauthorize the program permanently so that children with serious illnesses can have hope for new therapies, better health and even possibly cures.

GoodNewsCreatingHope_edited-4Congressman Butterfield’s (NC-1) bill, H.R. 4439—Creating Hope Reauthorization Act passed out of the House Committee on Energy & Commerce. Committee passage places this critical bill one step closer to becoming law. Butterfield said, “Every child who faces the devastation of a cancer or a life-threatening rare pediatric disease diagnosis deserves our best effort to provide support and ultimately, hope. The Creating Hope Act incentivizes the pharmaceutical industry to develop treatments and cures for children with rare life-threatening conditions, including cancer, through an extension of the rare pediatric disease priority review voucher program at the U.S. Food and Drug Administration (FDA). As the co-chair of the Childhood Cancer Caucus and the co-chair of the Rare Disease Caucus, I am excited and encouraged by the passage of a four-year extension of this critical program out of the Committee. I look forward to the life-changing and life-saving treatments this legislation will spur for children and their families.”

There are only 20 days before the Creating Hope Act expires.  Nancy Goodman is hoping to have the bill attached a continuing resolution to keep the government running after September 30th since a budget will not have been approved. The CR will be voted on September 30th. Let’s stay tuned to see what we can do to help.

Comment from Nancy Goodman, Kids-V-Cancer, champion of Creating Hope:

Dear Friends:
We are pleased to report that yesterday the House Energy and Commerce Committee passed the Creating Hope Reauthorization Act (HR 4439) with a four year extension to the pediatric voucher program. 
Next steps would be a vote by the full House as well as a vote by the Senate.
However, the pediatric voucher program expires in 20 days, on September 30, 2020.
Thus, we ask Congress to attach the Creating House Reauthorization Act to the continuing resolution, which is expected to be passed by September 30 to keep the government funded.   
The Creating Hope Reauthorization Act’s original language asks for a permanent reauthorization of the pediatric voucher program.  We are grateful for the Energy and Commerce’s extension but we believe seriously ill children will be best served by a permanent program.  We  look forward to working with Congress to make that happen.
A permanent program would maximize the impact of the voucher incentives by assuring drug developers that the pediatric vouchers will exist by the time their drugs are approved.
By any measure, the pediatric voucher program has been wildly successful.
  • Since the Creating Hope Act was first passed into law in 2012, the program has result in 24 new drugs for kids with rare and life-threatening illnesses.
  • Vouchers have been trading recently at $100 million, constituting a substantial incentive for pediatric drug development.
  • Moreover, the program has not resulted in any federal expenditures — FDA execution costs are covered by an additional user fees paid by pharmaceutical companies — and the voucher program does not result in higher drug prices for consumers.
We want to thank Chair Frank Pallone (D-NJ), Ranking Member Greg Walden (R- WA), Health Subcommittee Chair Anna Eshoo (D-CA) and Health Subcommittee Ranking Member Rep Michael Burgess (R-TX) for their continued support.
And as always, we thank our sponsors, Reps. G.K. Butterfield (D-NC) and Michael McCaul (R-TX) for their continued leadership on this bill and other pediatric cancer bills.
Thank you for your continued support.

Good News!  Senators Bob Casey (D-PA) and Susan Collins (R-ME) introduced The  Creating Hope Reauthorization Act (S. 4010) in the Senate. We are thankful to them for introducing a companion bill.   

The Creating Hope Act establishes an incentive for drugs to be developed expressly for children with rare diseases. The incentive is a priority review voucher that can be earned by a company that develops a rare pediatric disease drug. The vouchers come with rights to faster FDA review of any other drug, including a drug that would not be for any rare pediatric diseases.

PriorityReviewDrugs5_22_20_edited-1Since the passage of the Creating Hope Act pediatric priority review voucher program, the FDA has approved 24 new therapies for children with serious illnesses, six of which are for children with cancer.

Vouchers have traded for as much as $350 million, providing a significant incentive for drug development for seriously ill children. $2 billion in vouchers have been traded.

The Creating Hope Act has helped children like Emma Whitehead, who was treated with the first FDA approved drug for a gene therapy, Novartis’ Kymriah, for B-cell precursor ALL. Kyrmiah earned a voucher.  In addition, Y-mABs Therapeutics is using the pediatric priority review voucher program to develop exciting new therapies for children with neuroblastoma and other pediatric cancers.

George “G.K.” Butterfield Jr.Representative for North Carolina’s 1st congressional district, introduced  HR. 4439 on September 20, 2019

The Creating Hope Act Authorization has been endorsed by the following organizations:
3/32 Foundation, Adam’s Angels Ministry, Alex’s Army Childhood Cancer Foundation, Amanda Riley Foundation, Association of Pediatric Hematology Oncology Nurses, Braden’s Hope For Childhood Cancer, Bridge the Gap – SYNGAP Education and Research Foundation, Brooke’s Blossoming Hope for Childhood Cancer, Brown University/Hasbro Children’s Hospital, Caleb’s Crusade for Childhood Cancer, Cancer Care Manitoba, Cancer Free KIDS, Carson Leslie Foundation, CHEMOWARRIOR: the Eli Sidler Foundation, Children’s Hospital of Philadelphia, Chloe’s Journey of Faith Foundation, Christina Renna Foundation Inc., Circle of Care, Conner Cares, Curtana Pharmaceuticals, DADA2 Foundation, Daniel’s House Publications, DBSA, EveryLife Foundation for Rare Diseases, FFAME (Family, Friends and Allies of ME/cfs, Foster Tree Service, Gabriella’s Smile Foundation, Georgetown Lombardi Comprehensive Cancer Center, GIC Group/Global Food Safety Forum, Gold Rush Cure Foundation, Grace Way Foundation, Grandparents in Action, Harvard Medical School/ Massachusetts General Hospital, International Society of Paediatric Oncology (SIOP), Jack’s Angels, Jeffrey’s Voice, Joey’s Wings Foundation, Jonah’s Just Begun, Julia’s Grace Foundation, Kids vs Cancer, Kids Without Cancer, Kier’s Kidz, Lucy’s Love Bus, Mackey Children’s Cancer Foundation, MIB Agents, Michael Mosier Defeat DIPG Foundation, NanoValent Pharmaceuticals, National MPS Society, National Organization for Rare Disorders® (NORD), NF2 BioSolutions, Noah’s Bandage Project, Noah’s Hope, Oral Health Nursing Education and Practice, Pediatric Assessment, Learning & Support, Pediatric Cancer Foundation, Pediatric Valley Medical Center, Perlmutter Cancer Center at NYU Langone Health, Rally Foundation for Childhood Cancer Research, Rett’s Roost, Sadie Keller Foundation, Samuel Jeffers Childhood Cancer Foundation Section 32, St. Jude Children’s Research Hospital, Stephen T Marchello Scholarship Foundation, Super Sam Foundation, Swifty Foundation, Syndax Pharmaceuticals, Team G Childhood Cancer Foundation, Teen Cancer America, The Cooper Max Foundation, The Cure Starts Now North Texas, The Dandy Horse, Inc., The Jesse Heikkila Foundation, The Maeve McNicholas Memorial Foundation, The National Children’s Cancer Society, The Nicholas Conor Institute, The Progeria Research Foundation, The Rare Childhood Cancer Advocacy Group, The Scott Carter Foundation, The Steven G AYA Cancer Research Fund, The Valerie Fund, This Star Won’t Go Out, Toby Knapp Radio, Wade’s Army, We Believe Foundation, Wylie’s Day Foundation, Y-mAbs Therapeutics Inc., Biotechnology Innovation Organization
41 cosponsors (22D, 19R)
Bilirakis, Gus [R-FL12] (joined Sep 20, 2019)
Engel, Eliot [D-NY16] (joined Sep 20, 2019)
Hudson, Richard [R-NC8] (joined Sep 20, 2019)
Kelly, Mike [R-PA16] (joined Sep 20, 2019)
Kelly, Robin [D-IL2] (joined Sep 20, 2019)
McCaul, Michael [R-TX10] (joined Sep 20, 2019)
Mullin, Markwayne [R-OK2] (joined Sep 20, 2019)
Rush, Bobby [D-IL1] (joined Sep 20, 2019)
Speier, Jackie [D-CA14] (joined Sep 20, 2019)
Fitzpatrick, Brian [R-PA1] (joined Sep 24, 2019)
DeGette, Diana [D-CO1] (joined Oct 4, 2019)
Luria, Elaine [D-VA2] (joined Feb 25, 2020)
McMorris Rodgers, Cathy [R-WA5] (joined Feb 25, 2020)
Carson, André [D-IN7] (joined Mar 4, 2020)
Clarke, Yvette [D-NY9] (joined Mar 4, 2020)
Davis, Rodney [R-IL13] (joined Mar 4, 2020)
Rutherford, John [R-FL4] (joined Mar 4, 2020)
Blunt Rochester, Lisa [D-DE0] (joined Mar 11, 2020)
Barragán, Nanette [D-CA44] (joined Apr 23, 2020)
Soto, Darren [D-FL9] (joined Apr 23, 2020)
Cárdenas, Tony [D-CA29] (joined May 15, 2020)
Carter, Buddy [R-GA1] (joined Jul 29, 2020)
Griffith, Morgan [R-VA9] (joined Jul 29, 2020)
Kuster, Ann [D-NH2] (joined Jul 29, 2020)
Marshall, Roger [R-KS1] (joined Jul 30, 2020)
Cohen, Steve [D-TN9] (joined Aug 14, 2020)
DeFazio, Peter [D-OR4] (joined Aug 14, 2020)
Woodall, Rob [R-GA7] (joined Aug 14, 2020)
Balderson, Troy [R-OH12] (joined Aug 18, 2020)
Brooks, Mo [R-AL5] (joined Aug 18, 2020)
King, Steve [R-IA4] (joined Aug 18, 2020)
Lofgren, Zoe [D-CA19] (joined Aug 18, 2020)
Malinowski, Tom [D-NJ7] (joined Aug 18, 2020)
Marchant, Kenny [R-TX24] (joined Aug 21, 2020)
Porter, Katie [D-CA45] (joined Aug 21, 2020)
DeSaulnier, Mark [D-CA11] (joined Sep 1, 2020)
Fortenberry, Jeff [R-NE1] (joined Sep 1, 2020)
Lesko, Debbie [R-AZ8] (joined Sep 1, 2020)
McEachin, Donald [D-VA4] (joined Sep 1, 2020)
Bonamici, Suzanne [D-OR1] (joined Sep 11, 2020)
Sherrill, Mikie [D-NJ11] (joined Sep 11, 2020)